Acute Kidney InjuryLEON1NCT07751861
Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy: A Pragmatic Randomized Trial.
A study testing low concentrated citrate solution (18 mmol/L) and high concentrated citrate solution (136 mmol/L) in people with Acute Kidney Injury, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- low concentrated citrate solution (18 mmol/L) and high concentrated citrate solution (136 mmol/L)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient admitted to the intensive care unit with acute kidney injury requiring continuous kidney replacement therapy
Who cannot join
- expected duration of continuous kidney replacement therapy less than 96 hours
- prior continuous kidney replacement therapy before inclusion
- a known hypersensitivity to citrate, acute liver failure or liver cirrhosis Child-Pugh C
- persistent severe hemodynamic shock with decreased lactate clearance
- a high likelihood of dying within the first 24h after initiation of CKRT
- preexisting severe electrolyte disorders before CKRT initiation not attributable to Acute kidney injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy: A Pragmatic Randomized Trial
This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.
Read the detailed description
This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.
- Conditions
- Acute Kidney Injury
- Being tested
- low concentrated citrate solution (18 mmol/L), high concentrated citrate solution (136 mmol/L)
- Keywords
- regional citrate anticoagulation, continuous kidney replacement therapy, metabolic complications, electrolyte disorders
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low concentrated citrate solution (18 mmol/L)Device
use of a low concentrated citrate solution (18 mmol/L)
high concentrated citrate solution (136 mmol/L)Device
high concentrated citrate solution (136 mmol/L)
| Study group | Role | What they receive |
|---|---|---|
| Lo-RCA | Experimental | Low concentrated citrate solution 18 mmol citrate per liter Receives: Device: low concentrated citrate solution (18 mmol/L) |
| Hi-RCA | Experimental | High concentrated citrate solution 136 mmol citrate per liter Receives: Device: high concentrated citrate solution (136 mmol/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for additional electrolyte supplementation
Need for additional electrolyte supplementation : magnesium, phosphate, potassium expressed in grams of mmol during the 96 hour study period.
Measured: 96 hours
Secondary outcomes (2)
Time course of serum electrolyte concentrations
Evolution of the serum electrolytes concentrations (potassium, magnesium, phosphorus, sodium, total calcium, ionized calcium, pH, bicarbonate) during the 96 hour study period for each arm.
Measured: 96 hours
Incidence of electrolyte and acid-base disorders
Cumulative incidence of electrolyte and acid-base disorders (hyponatremia, hypernatremia, hypomagnesemia, hypophophatemia, hypokalemia, metabolic alkalosis, metabolic acidosis) in each arm during the 96 hour study period
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Oct 2023
- Primary completion31 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Verbrugghe, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751861
- Sponsor's protocol ID
- B3002022000171
- Acronym
- LEON1
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing will be done upon motivated request
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy: A Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT07751861
- Acronym / sponsor ID
- LEON1 / B3002022000171
- Conditions
- Acute Kidney Injury
- Keywords
- regional citrate anticoagulation, continuous kidney replacement therapy, metabolic complications, electrolyte disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.
Detailed description
This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lo-RCA | Experimental | Device: low concentrated citrate solution (18 mmol/L)Low concentrated citrate solution 18 mmol citrate per liter |
| Hi-RCA | Experimental | Device: high concentrated citrate solution (136 mmol/L)High concentrated citrate solution 136 mmol citrate per liter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient admitted to the intensive care unit with acute kidney injury requiring continuous kidney replacement therapy
Key exclusion criteria (6 listed)
- expected duration of continuous kidney replacement therapy less than 96 hours
- prior continuous kidney replacement therapy before inclusion
- a known hypersensitivity to citrate, acute liver failure or liver cirrhosis Child-Pugh C
- persistent severe hemodynamic shock with decreased lactate clearance
- a high likelihood of dying within the first 24h after initiation of CKRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low concentrated citrate solution (18 mmol/L)use of a low concentrated citrate solution (18 mmol/L) | Device | Lo-RCA |
| high concentrated citrate solution (136 mmol/L)high concentrated citrate solution (136 mmol/L) | Device | Hi-RCA |
Primary outcome
Need for additional electrolyte supplementation
Time frame: 96 hours
Need for additional electrolyte supplementation : magnesium, phosphate, potassium expressed in grams of mmol during the 96 hour study period.
2 secondary outcomes
Time course of serum electrolyte concentrations
Time frame: 96 hours
Incidence of electrolyte and acid-base disorders
Time frame: 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided. Sharing will be done upon motivated request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low concentrated citrate solution (18 mmol/L) and high concentrated citrate solution (136 mmol/L) in people with Acute Kidney Injury, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for additional electrolyte supplementation (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.